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A cluster-randomized effectiveness trial of Vi typhoid vaccine in India.
N Engl J Med. 2009 Jul 23; 361(4):335-44.NEJM

Abstract

BACKGROUND

Typhoid fever remains an important cause of illness and death in the developing world. Uncertainties about the protective effect of Vi polysaccharide vaccine in children under the age of 5 years and about the vaccine's effect under programmatic conditions have inhibited its use in developing countries.

METHODS

We conducted a phase 4 effectiveness trial in which slum-dwelling residents of Kolkata, India, who were 2 years of age or older were randomly assigned to receive a single dose of either Vi vaccine or inactivated hepatitis A vaccine, according to geographic clusters, with 40 clusters in each study group. The subjects were then followed for 2 years.

RESULTS

A total of 37,673 subjects received a dose of a study vaccine. The mean rate of vaccine coverage was 61% for the Vi vaccine clusters and 60% for the hepatitis A vaccine clusters. Typhoid fever was diagnosed in 96 subjects in the hepatitis A vaccine group, as compared with 34 in the Vi vaccine group, with no subject having more than one episode. The level of protective effectiveness for the Vi vaccine was 61% (95% confidence interval [CI], 41 to 75; P<0.001 for the comparison with the hepatitis A vaccine group). Children who were vaccinated between the ages of 2 and 5 years had a level of protection of 80% (95% CI, 53 to 91). Among unvaccinated members of the Vi vaccine clusters, the level of protection was 44% (95% CI, 2 to 69). The overall level of protection among all residents of Vi vaccine clusters was 57% (95% CI, 37 to 71). No serious adverse events that were attributed to either vaccine were observed during the month after vaccination.

CONCLUSIONS

The Vi vaccine was effective in young children and protected unvaccinated neighbors of Vi vaccinees. The potential for combined direct and indirect protection by Vi vaccine should be considered in future deliberations about introducing this vaccine in areas where typhoid fever is endemic. (ClinicalTrials.gov number, NCT00125008.)

Authors+Show Affiliations

National Institute of Cholera and Enteric Diseases, Kolkata, India.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19625715

Citation

Sur, Dipika, et al. "A Cluster-randomized Effectiveness Trial of Vi Typhoid Vaccine in India." The New England Journal of Medicine, vol. 361, no. 4, 2009, pp. 335-44.
Sur D, Ochiai RL, Bhattacharya SK, et al. A cluster-randomized effectiveness trial of Vi typhoid vaccine in India. N Engl J Med. 2009;361(4):335-44.
Sur, D., Ochiai, R. L., Bhattacharya, S. K., Ganguly, N. K., Ali, M., Manna, B., Dutta, S., Donner, A., Kanungo, S., Park, J. K., Puri, M. K., Kim, D. R., Dutta, D., Bhaduri, B., Acosta, C. J., & Clemens, J. D. (2009). A cluster-randomized effectiveness trial of Vi typhoid vaccine in India. The New England Journal of Medicine, 361(4), 335-44. https://doi.org/10.1056/NEJMoa0807521
Sur D, et al. A Cluster-randomized Effectiveness Trial of Vi Typhoid Vaccine in India. N Engl J Med. 2009 Jul 23;361(4):335-44. PubMed PMID: 19625715.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A cluster-randomized effectiveness trial of Vi typhoid vaccine in India. AU - Sur,Dipika, AU - Ochiai,R Leon, AU - Bhattacharya,Sujit K, AU - Ganguly,Nirmal K, AU - Ali,Mohammad, AU - Manna,Byomkesh, AU - Dutta,Shanta, AU - Donner,Allan, AU - Kanungo,Suman, AU - Park,Jin Kyung, AU - Puri,Mahesh K, AU - Kim,Deok Ryun, AU - Dutta,Dharitri, AU - Bhaduri,Barnali, AU - Acosta,Camilo J, AU - Clemens,John D, PY - 2009/7/24/entrez PY - 2009/7/25/pubmed PY - 2009/7/30/medline SP - 335 EP - 44 JF - The New England journal of medicine JO - N Engl J Med VL - 361 IS - 4 N2 - BACKGROUND: Typhoid fever remains an important cause of illness and death in the developing world. Uncertainties about the protective effect of Vi polysaccharide vaccine in children under the age of 5 years and about the vaccine's effect under programmatic conditions have inhibited its use in developing countries. METHODS: We conducted a phase 4 effectiveness trial in which slum-dwelling residents of Kolkata, India, who were 2 years of age or older were randomly assigned to receive a single dose of either Vi vaccine or inactivated hepatitis A vaccine, according to geographic clusters, with 40 clusters in each study group. The subjects were then followed for 2 years. RESULTS: A total of 37,673 subjects received a dose of a study vaccine. The mean rate of vaccine coverage was 61% for the Vi vaccine clusters and 60% for the hepatitis A vaccine clusters. Typhoid fever was diagnosed in 96 subjects in the hepatitis A vaccine group, as compared with 34 in the Vi vaccine group, with no subject having more than one episode. The level of protective effectiveness for the Vi vaccine was 61% (95% confidence interval [CI], 41 to 75; P<0.001 for the comparison with the hepatitis A vaccine group). Children who were vaccinated between the ages of 2 and 5 years had a level of protection of 80% (95% CI, 53 to 91). Among unvaccinated members of the Vi vaccine clusters, the level of protection was 44% (95% CI, 2 to 69). The overall level of protection among all residents of Vi vaccine clusters was 57% (95% CI, 37 to 71). No serious adverse events that were attributed to either vaccine were observed during the month after vaccination. CONCLUSIONS: The Vi vaccine was effective in young children and protected unvaccinated neighbors of Vi vaccinees. The potential for combined direct and indirect protection by Vi vaccine should be considered in future deliberations about introducing this vaccine in areas where typhoid fever is endemic. (ClinicalTrials.gov number, NCT00125008.) SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/19625715/A_cluster_randomized_effectiveness_trial_of_Vi_typhoid_vaccine_in_India_ DB - PRIME DP - Unbound Medicine ER -